NCT07071350 Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
| NCT ID | NCT07071350 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Virginia Commonwealth University |
| Condition | Autonomic Nervous System Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2025-09-02 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 148 participants in total. It began in 2025-09-02 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Many combat veterans (c-Vs), service members (SMs) and civilians with mild traumatic brain injury (mTBI, also termed concussion) suffer from persistent post-concussion symptoms (PPCS) that degrade physical and cognitive well-being and have been linked with early neurodegeneration. PPCS include somatosensory (e.g., headache, disturbed vision), vestibular (e.g., dizzy, clumsy), cognitive (e.g., executive function, memory) and affective symptoms (e.g., sleep disturbance, irritability, depression). A key pathological process that provokes and perpetuates PPCS is autonomic nervous system (ANS) dysfunction such as unremitting sympathetic nervous system activation that also exacerbates other pathology such as inflammation. ANS activity can be readily quantified by measuring heart rate variability (HRV), or the variation in heart rate over time, which serves as a valid index of both physiological and psychological health
Eligibility Criteria
Inclusion Criteria: * age 18 or older * History of military service * Self-Reported hx of 1 or more mild TBI * Most recent TBI more than 1 year ago * Significant Persistent Post-Concussion Symptom burden (Neurobehavioral Symptom Inventory \[NSI\] total score greater than or equal to 20). * Current Sleep Difficulties * Fluent English * Able to provide Informed Consent Exclusion Criteria: * Any TBI with severity greater than mild (i.e., Moderate or Severe TBI defined as initial injury loss of consciousness (LOC) duration \>30 minutes, posttraumatic amnesia (PTA) duration \>24 hours, or traumatic hemorrhage on head computerized tomography (CT) and determined by the study investigator based on information gathered during administration of the study's validated TBI structured interview instrument. * Conditions or medications that can affect HRV measurement (pacemaker or an implant that stimulates your heart (e.g., cardioverter-defibrillator or ICD); heart transplant or heart surgery within the last year, including bypass or other surgery, but not including a stent) * Hx of stroke * Mental conditions that may impede adherence (e.g., dementia, psychotic disorder, panic disorder)
Contact & Investigator
James Burch
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT07071350 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autonomic Nervous System Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07071350 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07071350 currently recruiting?
Yes, NCT07071350 is actively recruiting participants. Contact the research team at bret.brooks@vcuhealth.org for enrollment information.
Where is the NCT07071350 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT07071350 clinical trial?
NCT07071350 is sponsored by Virginia Commonwealth University. The principal investigator is James Burch at Virginia Commonwealth University. The trial plans to enroll 148 participants.